Comparative Evaluation of the Effectiveness of Diclofenac Sodium Versus Vitamin D on Myofascial Pain

Yuzuncu Yıl University

Status and phase: Completed; Phase 4

Conditions: Myofascial Pain Dysfunction Syndrome,Temporomandibular Joint

Treatments: Drug: Diclofenac Sodium; Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT06111573

YYU-10/31.05.2023

Details and patient eligibility

About

It has been reported in the literature that there is a significant relationship between bruxism and low serum vitamin D levels. It was aimed to compare the effectiveness of diclofenac sodium treatment versus vitamin D supplementation on symptoms in individuals with myofascial pain and vitamin D deficiency.

Full description

In the current literature, it has been reported that there is a significant relationship between teeth grinding and low serum vitamin D levels. Vitamin D has been shown to play an important role in the musculoskeletal and cardiovascular systems, as well as in the control of calcium and phosphate metabolism and in maintaining adequate blood levels of these minerals. Vitamin D deficiency has been associated with poor physical performance and low muscle strength. There are also studies to understand the relationship between TMJ disorders and vitamin D level (serum 25(OH) D). These studies reported a relationship between the presence of TMJ disorder and vitamin D deficiency.

NSAIDs are a large group of drugs that inhibit cyclooxygenases and thus prevent the formation of prostaglandins. Traditionally, it has been the most commonly prescribed group of medications for pain in the orofacial area. It is recommended to use these drugs regularly for at least 2 weeks to achieve an anti-inflammatory effect in individuals with TMJ disorders.

It was aimed to compare the effectiveness of diclofenac sodium treatment versus vitamin D supplementation on symptoms in individuals with myofascial pain and vitamin D deficiency.

Enrollment: 40 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Vitamin D deficiency,
• Myofascial pain complaint,
• Chronic pain,
• No missing teeth,
• Absence of open bite and/or crossbite.

Exclusion criteria

• Individuals who have undergone interventional or surgical procedures related to the temporomandibular joint,
• Temporomandibular joint pathology,
• Pregnancy or breastfeeding,
• Individuals who do not come for postoperative checks,
• Using different medications other than those recommended,
• Allergy to study drugs and materials to be used

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Vitamin D + Occlusal Splint

Experimental group

Description:

Vitamin D is a fat-soluble secosteroid. Vitamin D is very important in muscle and bone metabolism. Vitamin D is a vitamin with some anti-inflammatory and immune-modulating properties.

Treatment:

Dietary Supplement: Vitamin D

Diclofenac Sodium + Occlusal Splint

Active Comparator group

Description:

Diclofenac Sodium is a type of NSAID which has been found effective both as an analgesic and in reducing inflammation and is classified as weak and preferentially COX-2 selective.

Treatment:

Drug: Diclofenac Sodium